Medical anastomosis apparatus

ABSTRACT

A connector for use in providing an anastomotic connection between two tubular body fluid conduits in a patient. The connector is preferably a single, integral, plastically deformable structure that can be cut from a tube. The connector has axial spaced portions that include members that are radially outwardly deflectable from other portions of the connector. The connector is annularly enlargeable so that it can be initially delivered and installed in the patient in a relatively small annular size and then annularly enlarged to provide the completed anastomosis. The radially outwardly deflected members of the first and second portions respectively engage the two body fluid conduits connected at the anastomosis and hold those two conduits together in fluid-tight engagement. Apparatus for use in delivering and deploying a connector is also disclosed.

This application is a division of U.S. patent application Ser. No.09/527,668, filed Mar. 17, 2000, now U.S. Pat. No. 6,309,416 which is adivision of U.S. patent application Ser. No. 09/186,774, filed Nov. 6,1998 (now U.S. Pat. No. 6,113,612). Both of these prior applications arehereby incorporated by reference herein in their entireties.

BACKGROUND OF THE INVENTION

This invention relates to medical apparatus, and more particularly toapparatus for use in making anastomotic connections between tubular bodyfluid conduits in a patient.

There are many medical procedures in which it is necessary to make ananastomotic connection between two tubular body fluid conduits in apatient. An anastomotic connection (or anastomosis) is a connectionwhich allows body fluid flow between the lumens of the two conduits thatare connected, preferably without allowing body fluid to leak out of theconduits at the location of the connection. As just one example of aprocedure in which an anastomosis is needed, in order to bypass anobstruction in a patient's coronary artery, a tubular graft suppliedwith aortic blood may be connected via an anastomosis to the contraryartery downstream from the obstruction. The anastomosis may be betweenthe end of the graft and an aperture in the side wall of the coronaryartery (a so-called end-to-side anastomosis), or the anastomosis may bebetween an aperture in the side wall of the graft and an aperture in theside wall of the coronary artery (a so-called side-to-side anastomosis(e.g., as in published Patent Cooperation Treaty (“PCT”) patentapplication WO 98/16161, which is hereby incorporated by referenceherein in its entirety)). The graft may be natural conduit, artificialconduit, or a combination of natural and artificial conduits. If naturalconduit is used, it may be wholly or partly relocated from elsewhere inthe patient (e.g., wholly relocated saphenous vein or partly relocatedinternal mammary artery). Alternatively, no relocation of the graft maybe needed (e.g., as in above-mentioned application WO 98/16161 in whicha length of vein on the heart becomes a “graft” around an obstruction inan immediately adjacent coronary artery). More than one anastomosis maybe needed. For example, a second anastomosis may be needed between anupstream portion of the graft conduit and the aorta or the coronaryartery upstream from the obstruction in that artery. Again, this secondanastomosis may be either an end-to-side anastomosis or (as shown, forexample, in above-mentioned application WO 98/16161) a side-to-sideanastomosis. Alternatively, no second, upstream anastomosis may berequired at all (e.g., if the graft is an only-partly-relocated internalmammary artery).

The currently most common technique for making an anastomosis is tomanually suture the two tubular body fluid conduits together around anopening between them. Manual suturing is difficult and time-consuming,and the quality of the anastomosis that results is highly dependent onthe skill of the person doing the suturing. In the case of coronaryartery bypass procedures, one source of difficulty for suturing of ananastomosis may be motion of the heart. There is also increasinginterest in procedures which are less invasive or even minimallyinvasive. Such procedures have potentially important advantages forpatients, but they may increase the difficulty of performing manualsuturing of an anastomosis by reducing or limiting access to the sitewithin the patient at which the anastomosis must be made. Variousexamples of such less invasive or minimally invasive procedures areshown in above-mentioned application WO 98/16161, Goldsteen et al. U.S.Pat. No. 5,976,178, Sullivan et al. U.S. Pat. No. 6,120,432, filed Apr.23, 1997, Sullivan et al. U.S. patent application Ser. No. 08/869,808,filed Jun. 5, 1997, and Berg et al. U.S. patent application Ser. No.09/187,364, filed Nov. 6, 1998, all of which are hereby incorporated byreference herein in their entireties.

In view of the foregoing, it is an object of this invention to provideapparatus that can be used to make anastomotic connections in lieu ofmanual suturing.

It is another object of the invention to provide apparatus that can beused to make anastomotic connections even though access to the site ofthe anastomosis may be limited or even only indirect or remote.

It is still another object of the invention to provide apparatus thatcan be used to make anastomotic connections without the need for a highdegree of manual suturing skill.

It is yet another object of the invention to provide apparatus formaking anastomotic connections that is less adversely affected thanmanual suturing by adjacent or nearby body motion (e.g., motion of thepatient's heart).

It is still another object of this invention to provide apparatus forfacilitating the making of higher quality anastomotic connections morerapidly and with more consistent results than is possible with prior artmethods and apparatus such as manual suturing.

SUMMARY OF THE INVENTION

These and other objects of the invention are accomplished in accordancewith the principles of the invention by providing a connector for use inmaking an anastomotic connection between two tubular body fluid conduitsin a patient, the connector being of substantially one-piece or unitaryconstruction which extends annularly about a central longitudinal axis.The structure of the connector includes axially spaced first and secondportions, at least one of which includes members that are deflectableradially out from a remainder of the connector structure. In someembodiments both of the axially spaced first and second portions includemembers that are deflectable radially out from a remainder of thestructure. The connector structure is annularly enlargeable, preferablyby inflation of a balloon placed temporarily inside the connector. Thestructure of the connector preferably lends itself to formation byremoval of selected material from a single unitary tube. The connectoris typically made of metal which is plastically deformable (e.g., in theabove-mentioned radial outward deflections and annular enlargement).

The members that are deflectable radially out from the first portion ofthe connector structure are configured to engage the side wall of one ofthe two tubular body fluid conduits that are to be connected. Themembers that are deflectable radially out from the second portion of theconnector structure are configured to engage the side wall of the otherof the two body fluid conduits that are to be connected. Alternatively,one of the two portions of the connector can be secured (preferablypre-secured) to the associated conduit by other means such as sutures.Annular expansion of the connector preferably causes the first andsecond portions of the connector structure to move toward one anotheralong the central longitudinal axis of the connector, thereby causingthe connector to draw the two tubular body fluid conduits together atthe anastomosis between them. This helps produce an anastomosis which isfluid-tight (i.e., from which body fluid does not leak).

The connectors of this invention can be used to provide eitherend-to-side or side-to-side anastomoses. The connector may be firstattached to one of the body fluid conduits to be connected (e.g., an endportion of a graft conduit), and then delivered along with the attachedend of the first conduit to the connection point with the secondconduit, where the connector is fully deployed to produce an anastomosisbetween the first and second conduits. Prior to full deployment theconnector preferably has a relatively small circumference, whichfacilitates delivery and initial installation in the patient, even atrelatively remote or inaccessible locations in the patient. For example,the connector can be delivered via lumens of body fluid conduits in thepatient and/or relatively small-diameter instrumentation such as acannula or laparascopic-type device. Final installation can be performedsubstantially solely by inflation of a balloon temporarily disposed inthe connector. No direct manipulation of the connector may be needed.All of these attributes facilitate-use of the connector at remote orinaccessible locations in the patient. The connector therefore lendsitself to use in less invasive or minimally invasive procedures.

Instrumentation for facilitating installation of the connector throughthe side wall of a body fluid conduit is also disclosed. Thisinstrumentation has a gradually tapered distal nose portion with anouter surface that is free of features that could snag on the side wallof the body fluid conduit to be penetrated by the nose portion. At leastthe portion of the connector that must pass through the body fluidconduit side wall is completely covered by the instrumentation untilthat portion of the connector is through the side wall. These featuresof the instrumentation help it penetrate the body fluid conduit sidewall with no snagging and with minimal trauma. Thereafter the distalnose portion can be shifted distally relative to the connector to exposethe connector in position through the side wall. Other parts of theinstrumentation (e.g., an inflatable balloon) can then be operated tocomplete the deployment of the connector.

Further features of the invention, its nature and various advantageswill be more apparent from the accompanying drawings and the followingdetailed description of the preferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified planar development of the structure of anillustrative embodiment of a connector constructed in accordance withthis invention.

FIG. 2 is a simplified perspective view of the actual structure of theconnector which is shown in planar development in FIG. 1.

FIG. 3 is a simplified elevational view of the FIG. 2 structure aftersome further processing in accordance with the invention.

FIG. 4 is a simplified planar development of the structure of FIGS. 1-3showing that structure's capacity for annular enlargement in accordancewith the invention.

FIG. 5 is a simplified elevational view of the structure of FIG. 3 withsome additional structure in accordance with the invention.

FIG. 6 is a simplified elevational view, partly in section, of thestructure of FIG. 5 with still more additional structure in accordancewith the invention.

FIG. 7 is a simplified sectional view of the structure of FIG. 6 withadditional illustrative apparatus shown for use in delivering anddeploying the FIG. 6 structure in a patient in accordance with theinvention.

FIG. 8 is a simplified elevational view, partly in section, showing anearly stage in use of the FIG. 7 apparatus in accordance with theinvention.

FIG. 9 is a view similar to FIG. 8, but with more elements shown insection, and showing a later stage in use of the FIG. 7 apparatus inaccordance with the invention.

FIG. 10 is a view similar to FIG. 9 showing a still later stage in useof the FIG. 7 apparatus in accordance with the invention.

FIG. 11 is a view similar to FIG. 10 showing the end result of using theFIG. 7 apparatus in accordance with the invention.

FIG. 12 is a view similar to FIG. 1 for another illustrative embodimentof a connector constructed in accordance with the invention.

FIG. 13 is a view similar to FIG. 4, but for the embodiment of FIG. 12.

FIG. 14 is a simplified perspective view showing the connector of FIG.12 with other elements in accordance with the invention.

FIG. 15 is another simplified perspective of a later stage in use ofsome of the elements shown in FIG. 14.

FIG. 16 is another simplified perspective view, partly in section, of astill later stage in use of the elements shown in FIG. 15.

FIG. 17 is another view, generally similar to FIG. 16, showing an evenlater stage in use of the elements shown in FIG. 16.

FIG. 18 is a simplified perspective view of a completed anastomosisincluding the connector of FIG. 12.

FIG. 19 is another view, partly in section, of the anastomosis of FIG.18.

FIG. 20 is a simplified perspective view of an illustrative embodimentof a starting structure for use in making connectors in accordance withthe invention.

FIG. 21 is a simplified elevational view, partly in section,illustrating a possible modification of connectors in accordance withthe invention.

FIG. 22 is a simplified elevational view, partly in section,illustrating another possible modification of connectors in accordancewith the invention.

FIG. 23 is a simplified sectional view of an alternative finishedanastomosis in accordance with the invention.

FIG. 24 is a view similar to FIG. 4 for still another illustrativeembodiment of a connector constructed in accordance with the invention.

FIG. 25 is a view similar to FIG. 11 for a completed anastomosisemploying a connector of the type shown in FIG. 24.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIG. 1 shows a planar development of what is actually an integral,one-piece (unitary), annular structure 10. In particular, the left andright edges of the structure shown in FIG. 1 are actually joined to andintegral with one another. Thus the actual structure is as shown in FIG.2, although FIG. 1 is useful to more clearly reveal the details ofvarious features of the structure. A central longitudinal axis 12 aboutwhich structure 10 is annular is shown in FIG. 2.

An illustrative material for structure 10 is 304 stainless steel. Otherexamples of suitable materials include tantalum, tungsten, platinum, andnitinol. Structure 10 may be advantageously produced by starting with asingle, unitary metal tube and removing selected material until only thestructure shown in FIG. 2 remains. For example, laser cutting may beused to remove material from the starting tube in order to producestructure 10. Although connectors 10 can be made in various sizes forvarious uses, a typical connector has an initial outside diameter in therange from about 0.040 to about 0.065 inches, an initial length of about4.0 mm, and a material thickness of about 0.004 inches.

Connector 10 may be described as including axially spaced first andsecond portions 20 and 40, respectively. First portion 20 includes aplurality of annularly spaced members 22 that in this case have free endportions 24 that are sharply pointed and that point toward secondportion 40. Each of members 22 is deflectable radially out from theremainder of structure 10 as shown, for example, in FIG. 3. This outwarddeflection is preferably at least partly plastic.

Second portion 40 also includes a plurality of annularly spaced members42 that in this case have free end portions 44 that are sharply pointedand that point toward first portion 20. Each of members 42 isdeflectable radially out from the remainder of structure 10 as shown,for example, in FIG. 3. Again, this outward deflection is preferably atleast partly plastic.

The above-mentioned outward deflection of elements 22 and 42 can beproduced by putting the connector on a mandrel and prying elements 22and 42 radially outward.

Connector 10 is formed in such a way that it is annularly enlargeable(e.g., by inflation of a balloon that is temporarily disposed inside theconnector). The annularly expanded condition of connector 10 is shown inFIGS. 4, 10, and 11. The annular expandability of connector 10 isprovided by making the connector with a plurality of annularly adjacent,annularly enlargeable cells. For example, a typical cell includesannularly spaced, but adjacent, longitudinal members 50 a and 52 a. Theaxially spaced ends of this pair of members are connected to one anotherat 54 a and 56 a. The next annularly adjacent similar cell includeselements 50 b, 52 b, 54 b, and 56 b. Annularly adjacent ones of thesecells are connected to one another (e.g., as at 66 a) at locations whichare axially medial to their axial end connections 54 and 56. In this waystructure 10 is annularly enlargeable by annularly enlarging each of theabove-mentioned cells (see FIG. 4).

In addition to the cells that are described above, structure 10 includesother, similarly annularly expandable cells that are axially andannularly offset from the first-described cells. A representative one ofthese other cells includes annularly adjacent longitudinal members 60 aand 62 a, the axially spaced ends of which are connected at 64 a and 66a. (It should be noted that part of member 60 a is common with part ofmember 52 a, and part of member 62 a is common with part of member 50b.) The next annularly adjacent cell of this kind includes components 60b, 62 b, 64 b, and 66 b. Annularly adjacent cells of this kind areconnected to one another at locations like 54 b, which are axiallymedial the axial endpoints 64 and 66 of those cells. Thus again thestructure is annularly enlargeable by annularly enlarging these cells asshown, for example in FIG. 4.

It will be appreciated that as structure 10 annularly enlarges, itgenerally axially shortens. In other words, as cells 50/52/54/56 and60/62/64/66 widen in the annular direction, they shorten in the axialdirection. Thus annular enlargement of structure 10 decreases the axialspacing between portions 20 and 40, and more particularly decreases theaxial spacing between member 22, on the one hand, and members 42, on theother hand.

A typical use of connector 10 is, in a coronary artery bypass procedure,to provide an anastomosis between an axial end portion of a tubulargraft conduit and an aperture in a side wall of a coronary artery. Forthis kind of use connector 10 may be loaded on an uninflated balloon 110near the distal end of a balloon catheter 100 as shown in FIG. 5. Inother words, connector 10 and catheter 100 are assembled so thatconnector 10 extends annularly around uninflated balloon 110.

Graft conduit 120 is then placed annularly around the first portion 20of connector 10 and the adjacent portion of catheter 100 as shown inFIG. 6. Graft conduit may be natural body tissue (e.g., a length of thepatient's saphenous vein harvested for use as a graft, a partly severedinternal mammary artery, etc.), an artificial graft (e.g., as shown inGoldsteen et al. U.S. Pat. No. 5,976,178, or published PCT patentapplication WO 98/19632, both of which are hereby incorporated byreference herein in their entireties), or a combination of natural andartificial conduits (e.g., a length of natural conduit disposedsubstantially concentrically inside a length of artificial conduit).Graft conduit 120 is placed on assembly 10/100 so that radiallyoutwardly deflected members 22 penetrate and pass through the side wallof the graft conduit (e.g., as a result of compressing the graft againstthe fingers, thereby forcing the fingers to pierce through the graftwall). The sharpened free ends of members 22 facilitate penetration ofconduit 120 by members 22. The blunt rear surfaces of enlarged free endportions 24 resist withdrawal of members 22 from conduit 120 aftermembers 22 have penetrated the conduit. The graft may be additionally oralternatively directly sutured to the connector body. If the alternativeof suturing graft 120 to the connector is used, then the first portion20 of the connector may not need radially outwardly deflectable members22 for engagement of the graft conduit.

As an alternative to securing graft 120 to connector 10 after balloon110 has been associated with the connector, balloon 110 may be installedin connector 10 after the graft has been secured to the connector.

Illustrative apparatus 200 for delivering connector 10 and graft 120 toa location in a patient requiring a graft and an anastomosis, and forthen deploying the connector and graft, is shown in FIG. 7. Apparatus200 includes an optional guide wire 210, which may be first installed inthe patient along the route that the remainder of the apparatus is laterto follow to reach the desired location in the patient. The remainder ofthe apparatus is then slid into the patient along guide wire 210.Alternatively, guide wire 210 may be omitted, or a leading guide member(e.g., a wire) may be fixedly mounted on the distal (leftward in FIG. 2)end of the remainder of the apparatus. The wire allows precise trackingof the nose cone 220 and delivery system 200 into a patient's body fluidconduit (e.g., a coronary artery 300 as shown in FIGS. 8-10 anddescribed below).

Apparatus 200 includes a gradually tapered distal nose portion ordilator 220 which extends annularly around a central, longitudinallyextending, guide wire lumen 222. Distal nose portion 220 has asubstantially conical outer surface with a cone angle A, which ispreferably less than about 15° (e.g., in the range from about 5° toabout 15°, more preferably in the range from about 5° to about 10°).Such gradual tapering of nose portion 220 is desirable to enable noseportion to gradually enlarge an aperture in a side wall of a body fluidconduit to which graft 120 is to be connected without snagging on thatconduit side wall. This geometry allows optimal passage across a bodyconduit wall (e.g., a coronary artery wall as shown in FIG. 8 anddescribed below) with minimal wall damage, with minimal force beingrequired, and with no catching or snagging on the wall. Distal noseportion 220 may have cutting edges to further facilitate entry through abody fluid conduit side wall.

Distal nose portion 220 is connected to tube 230, which extendsproximally from the nose portion annularly around guide wire 210. Thusthe lumen of tube 230 constitutes a proximal continuation of guide wirelumen 222. Tube 230 may be made of stainless steel hypotube, whichallows the depicted apparatus to be pushed or pulled axially along guidewire 210.

A proximal portion of distal nose portion 220 is hollowed out asindicated at 224 to receive balloon 110, connector 10, and a distalportion of graft 120 substantially coaxially around a medial portion oftube 230. For this arrangement balloon 110 is provided as a hollowannulus at or near the distal end of hollow tubular member 100. The sidewall of tube 100 may include a separate lumen (not shown butconventional for balloon catheters) through which pressurized inflationfluid may be supplied from a proximal region of the apparatus to balloon110. Elements 100 and 110 are slidable axially along the outer surfaceof tube 230. Insertion of elements 10, 110, and 120 (FIG. 6) into theannular recess 224 in distal nose portion 220 deflects the radiallyouter-most portions of members 22 back over graft 120 as shown in FIG.7. Tube 240, disposed substantially coaxially around element 100 insidegraft 120 so that its distal end bears against members 22, may be usedto help load elements 10, 110, and 120 into recess 224, and also to holdconnector 10 in place in recess 224 during delivery of the connector tothe anastomosis site in the patient.

FIG. 8 shows a typical use of apparatus 200 to deliver graft 120 forconnection to an aperture in a side wall of a patient's tubular bodyconduit 300 (e.g., a coronary artery requiring a bypass graft). Guidewire 210 is first installed through a small aperture in the side wall ofthe conduit. The natural elastic recoil of the conduit 300 side wallseals the aperture around the guide wire so that there is little or nobody fluid (e.g., blood) leakage out of the conduit via the aperture.The tapered distal nose portion 220 of apparatus 200 is then graduallyforced into the aperture (e.g., by using tube 230 to push portion 220distally into the aperture) to dilate the aperture. The natural elasticrecoil of the conduit 300 side wall tissue continues to keep theaperture sealed or substantially sealed around portion 220.

When distal nose portion 220 has been pushed far enough into theaperture in the side wall of conduit 300 so that connector 10 is partway through the aperture, further distal motion of elements 10, 100,110, and 120 can be stopped (e.g., by holding a proximal portion ofelement 100 stationary). Tube 240 is then pulled proximally out of thepatient. Thereafter, distal nose portion 220 is pushed farther intoconduit 300 (e.g., by continuing to push distally on a proximal portionof element 230). This causes distal nose portion 220 to separate fromconnector 10, thereby exposing the connector and leaving it in theaperture through the conduit 300 side wall as shown in FIG. 9.

The next step in use of apparatus 200 is to inflate balloon 110 as shownin FIG. 10. The balloon is typically sized to a specific anastomosissize (e.g., 3 millimeters diameter, 4 millimeters diameter, etc.).Inflation of the balloon forces connector 10 to annularly enlarge byenlarging cells 50/52/54/56 and 60/62/64/66 in the annular direction. Inaddition, the portions of members 60 and 62 that are adjacent toelements 64 (as well as elements 64 and 42) are deflected radially outbeyond other portions of the connector inside the side wall of conduit300, thereby causing the extreme distal end of graft 120 to similarlyflare out inside that side wall. This outward flaring of portions ofconnector 10 and graft 120 helps secure the connector and graft to theside wall of conduit 300, and also helps seal the graft to the conduit.The axial shortening of connector 10 that accompanies annularenlargement ensures that graft 120 is drawn into secure and fluid-tightengagement with conduit 300. The free ends of members 42 preferablypenetrate the side wall of conduit 300 to further secure connector 10and graft 120 in the aperture in the side wall. Members 50, 52, 56, and24 may also flare out somewhat outside the side wall of graft 300 tohelp ensure that graft 120 remains open where it connects to conduit300. Assuming that the connector is approximately properly positionedrelative to the side wall of conduit 300 prior to inflation of balloon110, the connector is effectively self-centering on the conduit 300 sidewall as the balloon is inflated.

The next step in use of apparatus 200 is to deflate balloon 110 andwithdraw all of elements 100, 110, 210, 220, and 230 (e.g., by pullingthem proximally out of graft 120). This leaves the axial end portion ofgraft 120 connected to the side wall of conduit 300 by annularlyenlarged connector 10 as shown in FIG. 11. In particular, in thisexample connector 10 provides an end-to-side anastomosis between graft120 and conduit 300. Body fluid from graft 120 is able to flow intoconduit 300 via this connection. Connector 10 presses graft 120 radiallyoutward against the aperture through the side wall of conduit 300 allthe way around that aperture, thereby preventing body fluid from leakingout of conduits 120 and 300. Connector 10 also prevents the end ofconduit 120 from pulling out of the side wall of conduit 300.

Another illustrative embodiment of a connector 410 in accordance withthis invention is shown (in simplified planar development) in FIG. 12.Again, although connector 410 can be made in various sizes for varioususes, a typical initial length of connector 410 is about 4.0 mm, and atypical initial outside diameter is in the range from about 0.040 toabout 0.065 inches. A typical shaft length for members 422 is about0.0539 inches, and a typical shaft width for those members is about0.0050 inches. As in the case of connector 10, connector 410 may be cutfrom a single integral tube. A typical thickness for the material ofconnector 410 is about 0.004 inches. Suitable materials for connector410 include stainless steel, tantalum, tungsten, platinum, and nitinol.

Connector 410 may be described as including axially spaced first andsecond portions 420 and 440, respectively. First portion 420 includes aplurality of annularly spaced first members 422 having free end portions424 that initially point axially away from second portion 440. However,members 422 are deflectable radially out from other parts of theconnector, and, if desired, free end portions 424 can be curved back sothat they point toward second portion 440 (see FIG. 15).

The first portion 420 of connector 410 may also be said to include thelower portions (below members 454) of cells, each of which includes onemember 460, one member 462, one member 464, and one member 466. Forexample, the left-most cell shown in FIG. 12 includes substantiallyparallel members 460 a and 462 a joined at their axially spaced ends bymembers 464 a and 466 a. Annularly adjacent cells are joined by members454 at points that are axially medial their axial ends. For example, thecell that includes member 462 a is joined to the cell that includesmember 460 b by members 454 b. The portions of members 460 and 462 belowmembers 454 are also deflectable radially out from other portions of theconnector.

The second portion 440 of connector 410 may be said to include theportions of members 460 and 462 above members 454. These portions ofmembers 460 and 462 are also deflectable radially out (as loops460/462/464) from other portions of the connector. If desired, loops460/462/464 could also have fingers or barbs on them like members 42 inthe embodiment of FIGS. 1-11.

Connector 410 is annularly enlargeable by deforming members 460 and 462to enlarge each of the above-described cells in the annular direction asshown in greatly simplified form in FIG. 13.

FIG. 14 shows an illustrative embodiment of tooling 500 that can be usedto facilitate attachment of a graft conduit 120 to connector 410.Tooling 500 includes a mandrel with a conical end portion, the pointedfree end of which is small enough to fit axially into connector 410 inits initial relatively small annular size. As connector 410 is forcedfarther onto the conical end portion of mandrel 500, the cone of themandrel begins to deflect members 422 radially out from other portionsof the connector. Graft conduit 120 can be placed around mandrel 500 andshifted axially toward connector 410 until an axial end portion ofconduit 120 axially overlaps outwardly deflected members 422. The freeend portions of members 422 can then be pried out through the side wallof conduit 120 as shown in FIG. 15 to secure connector 410 to conduit120. Mandrel 500 can be pulled proximally out of graft 120 and connector410 at any suitable time. Use of mandrel 500 in this way helps ensurethat members 422 penetrate the side wall of conduit 120 substantiallyequidistantly in the annular direction around the conduit. This helpsavoid excessive stretching of any angular segment of graft 120 whenconnector 410 is subsequently expanded by balloon 110.

After connector 410 has been attached to graft 120 as shown in FIG. 15,an inflatable balloon like balloon 110 (with tube 100) can be insertedinto the connector in a manner similar to what is shown in FIG. 6.Elements 100, 110, 120, and 410 can then be loaded into apparatus like200 in a manner similar to what is shown in FIG. 7 (except that in thiscase the free ends 424 of members 422 will typically point in the distaldirection rather than in the proximal direction as is true for the freeends 24 of members 22 in FIG. 7). Apparatus 200 can then be used toinstall connector 410 and graft 120 in a patient in a manner similar tothe installation shown in FIGS. 8-11. FIG. 16 shows the second portion440 after it has been conveyed through the side wall of conduit 300 byapparatus 200 and apparatus 200 has been shifted distally farther intoconduit 300 to expose the connector. FIG. 17 shows second portion loops460/462/464 deployed (radially outwardly deflected), but the remainderof the connector not yet annularly expanded. A shaped balloon or dualballoon system may be utilized to achieve this. For example, one of twoaxially adjacent balloons may be used to help form distal retentionfingers 460/462/464 as shown in FIG. 17. The second of the two balloonsis thereafter used to annularly expand the remainder of the connectorand the anastomosis opening. Alternatively, a single “bulbous” shapedballoon may be used to produce a temporary intermediate condition likethat shown in FIG. 17, and to then annularly enlarge the remainder ofthe connector and the anastomosis opening. As still another possibilitythe distal retention fingers 460/462/464 may be self-actuating (i.e.,spring-biased) and not require balloon assist to spring out to thecondition shown in FIG. 17. For example, distal retention fingers460/462/464 may be preformed to deflect radially outward in a mannersimilar to the radially outward preform that is given to elements 22 and42 in FIG. 3.

The final anastomosis employing connector 410 is shown in FIGS. 18 and19. In particular, as shown in FIGS. 18 and 19 connector 410 has beenannularly expanded by enlargement of the cells 460/462/464/466 in theannular direction. The portions of members 460 and 462 that compriseportion 440 of the connector have been deflected radially out from otherportions of the connector inside conduit 300, thereby functioning tosecure connector 410 and graft 120 to conduit 300. Members 422 aredeflected radially out from other portions of the connector and passthrough the axial end portion of graft 120. The free end portions ofmembers 422 point toward the second portion 440 of the connector,thereby ensuring that the end of graft 120 cannot slip away from itsbody-fluid-sealing abutment with the side wall of conduit 300. Theannularly expanded medial portion of connector 410 holds open theaperture in the side wall of conduit 300, as well as the attached end ofgraft 120, thereby ensuring unobstructed body fluid flow through theanastomosis between conduits 120 and 300.

Still another illustrative embodiment of a connector 610 in accordancewith this invention is shown in greatly simplified, annularly expanded,planar development in FIG. 24. Connector 610 is configured for use inperforming a side-to-side anastomosis between two body fluid conduits300 a and 300 b as shown in FIG. 25. Connector 610 has a constructionlike two portions 40 of connector 10 connected together. Thus members642 a and 642 b are constructed and operate like members 42 in connector10. Similarly, members 660 are constructed and operate generally likemembers 60 and 62 in connector 10, and elements 664 and 666 areconstructed and operate generally like elements 64 and 66, respectively,in connector 10.

Connector 610, in an initially relatively small annular size and mountedon a balloon, is insertable through adjacent apertures in the side wallsof body fluid conduits 300 a and 300 b. For example, apparatus like 200can be used to deliver connector 610 to such a site via the lumen of oneof conduits 300 and to then position the connector so that it spans bothconduits. Apparatus 200 is then shifted relative to connector 610 in amanner generally similar to FIG. 9 to expose the connector. The balloon110 associated with the connector is then inflated to annularly enlargethe connector to the condition shown in FIG. 25. In particular, thisannular expansion causes members 642 a to penetrate the side wall ofconduit 300 a annularly around the anastomotic opening, and also causesmembers 642 b to penetrate the side wall of conduit 300 b annularlyaround the anastomotic opening. As with the other connectors of thisinvention, annular enlargement of connector 610 is accompanied by axialshortening, which helps to draw the side walls of conduits 300 a and 300b together annularly around the connector, thereby providing the desiredfluid-tight anastomosis between the conduits. When the anastomosis isthus complete, the balloon inside the connector is deflated and all theapparatus is withdrawn through the anastomosis.

It will be understood that the foregoing is only illustrative of theprinciples of this invention, and that various modifications can be madeby those skilled in the art without departing from the scope and spiritof the invention. For example, the number and shape of the annularlyenlargeable connector cells can be different from what is shown in thedrawings herein. The number of axially adjacent rows of annularlyenlargeable cells can be different from the numbers of such rows thatare shown herein (i.e., two rows of cells in the case of connectors 10and 610 or one row of cells in the case of connector 410). For example,a connector may have three, four, or more rows of cells. The cells mayhave any of many forms, depending on the desired degree of expansion andfinal radial strength. The number of cells, the number of rows of cells,the size of the cells, and the geometry of the cells can all be selectedto control the expansion, strength, and sizing of the finishedconnector. The number and shape of the radially outwardly deflectableconnector members can also differ from what is shown herein. Techniquesand apparatus different from what is shown and described herein can beused for attaching a connector of this invention to a graft conduitand/or installing the connector in a patient. Instead of the extreme endof graft 120 being inside conduit 300, the connector of this inventionmay be configured to secure the end of the graft 120 against the outsideof the side wall of conduit 300 in an end-to-side anastomosis as shownin FIG. 23. The nose cone 220 of apparatus 200 may not need to cover theproximal fingers 22 or 422 of the connector. Instead, the proximalfingers can extend to an outer circumference which is larger than theouter circumference of nose cone 220. This allows the proximal fingersto be used as a stop which prevents the connector from going too farthrough the aperture in the side wall of conduit 300. In other words,the radially outer ends of proximal fingers 22 or 422 come into contactwith the outer surface of the side wall of conduit 300 and thereby stopthe connector from going any farther into that conduit.

Although considerable variation in the connectors of this invention isthus possible and contemplated, in general such connectors comprise aunitary structure disposed annularly about a longitudinal axis (e.g.,axis 12 in FIG. 2). The connector structure generally has axially spacedfirst and second portions (e.g., 20 and 40, 420 and 440, or 640 a and640 b in the depicted illustrative embodiments). The first portiongenerally has a plurality of annularly spaced first members that aredeflectable radially out from a remainder or other generally axiallymedial portion of the structure. For example, in the illustrativeembodiment shown in FIGS. 1-11 these first members include elements 22.In the illustrative embodiment shown in FIGS. 12-19 these first membersinclude elements 422. In the illustrative embodiment shown in FIGS. 24and 25 these first members include elements 642 a. The second portionmay also have a plurality of annularly spaced second members that aredeflectable radially out from a remainder or other generally axiallymedial portion of the structure. For example, in the illustrativeembodiment shown in FIGS. 1-11 these second members include elements 44and (later in use of the connector) the portions of elements 60 and 62that are above elements 54 in FIG. 1. In the illustrative embodimentshown in FIGS. 12-19 the second members include U-shaped structures thatare the portions of elements 460, 462, and 464 above elements 454 inFIG. 12. In the illustrative embodiment shown in FIGS. 24 and 25 thesesecond members include members 642 b. Also, in general, the connectorstructures of this invention are annularly enlargeable. For example, inthe illustrative embodiment shown in FIGS. 1-11 the connector isannularly enlargeable by enlarging cells 50/52/54/56 and 60/62/64/66 inthe annular direction as shown, e.g., in FIG. 4. Similarly, in theillustrative embodiment shown in FIGS. 12-19 the connector is annularlyenlargeable by enlarging cells 460/462/464/466 in the annular directionas shown, e.g., in FIG. 13. And in the embodiment shown in FIGS. 24 and25 the connector is annularly enlargeable by enlarging cells 660/664/666in the annular direction.

It will be appreciated that, in general, the structure of the connectorsof this invention is such that radial enlargement of the connectorreduces the axial spacing between the above-mentioned first and secondmembers. This helps the connector draw together in a fluid-tight way thetwo body fluid conduits that are to be connected by the connector. Inthe embodiment shown in FIGS. 1-11, for example, annular enlargement ofcells 60/62/64/66 causes a decrease in the axial spacing between members22, on the one hand, and members 42, on the other hand. Similarly, inthe embodiment shown in FIGS. 12-19 annular enlargement of cells460/462/464/466 causes a decrease in the axial spacing between members422, on the one hand, and the portions of elements 460 and 462 aboveelements 454 in FIG. 12, on the other hand. And in the embodiment shownin FIGS. 24 and 25 annular enlargement of the connector decreases theaxial spacing between members 642 a, on the one hand, and members 642 b,on the other hand. The above-described axial shortening of the connectoradvantageously applies compressive forces (for sealing) to the bodyfluid conduits being connected.

In general, most of the deformation of the connectors of this inventionis preferably plastic strain and therefore permanent. The deformationthus referred to includes both the above-described radially outwarddeflection of members like 22, 42, 422, 642, etc., and theabove-described radial enlargement of the connector.

The radially outwardly deflectable members or portions of the connectormay be barbs, hooks, spikes, loops, or suture rings.

The connectors of this invention may be constructed so that differentportions of the connector annularly enlarge in response to differentamounts of applied annular enlargement force. For example, in theembodiment shown in FIGS. 1-11, the portions of the structure aboveelements 54 in FIG. 1 may be made so that they are less resistant toinflation of a balloon 110 inside the connector than portions of thestructure below elements 54 in FIG. 1. In an application of the typeshown in FIGS. 1-11 this causes these less resistant portions toannularly enlarge by deflecting radially out inside conduit 300 beforethe remainder of the connector begins to significantly annularlyenlarge. This early response of the less resistant portions insideconduit 300 may help to ensure that the connector does not slip out ofengagement with conduit 300 during annular enlargement of the connector.This technique of making different portions of the connector withdifferent strengths can be used to provide any sequence or phasing ofannular enlargement of various portions of the connector. Alternativelyor additionally, the connector can be shaped, molded, or phased in anydesired way by providing a balloon structure 110 which is shaped,molded, or phased in that way. For example, balloon structure 110 maycomprise two or more separately inflatable balloons of the same ordifferent inflated circumferential size. Two such balloons may beaxially displaced from one another inside the connector so that axiallydifferent portions of the connector can be annularly enlarged atdifferent times and/or by different amounts.

Radiologically (e.g., x-ray) viewable markers can be used anywhere onthe connectors and/or delivery apparatus (e.g., 200) of this inventionto facilitate radiologic observation of the proper placement anddeployment of a connector in a patient if the connector-utilizingprocedure is such that more direct visual observation is not possible orsufficient. One way to enhance the radiologic viewability of connectorsin accordance with this invention is to make them from clad tubing. Cladtubing has two (or more) substantially concentric layers of metal, eachwith a desired property. As shown in FIG. 20, for example, clad tubing500 has a tantalum layer 502 over a stainless steel layer 504. Thetantalum layer 502 provides radiodensity, thereby making a connector 10,410, or 610 that is cut from tube 500 radiologically viewable. Thestainless steel layer 504 provides rigidity to the connector. The medialsection can be ground to reduce the thickness ratio to favor thetantalum. This improves the ability for balloon expansion. Although tube500 (and the resulting connector 10, 410, or 610) may thus be made oftwo or more layers of different materials, the tube and the connectorare still accurately described as unitary, one-piece, or integral. As analternative to using clad tubing, the connector may be plated with aradiologic material to give it a desired radiodensity. Another exampleof a material suitable for radiologic layer 502 is platinum.

Small polyester or other polymer patches or bands may be used on or inassociation with a connector of this invention to help seal andcoagulate blood. Such patches may be inserted over individual fingers asshown, for example, at 522 in FIG. 21. Alternatively, such a band or webmay be provided around the medial portion of connector 10, 410, or 610as shown, for example, at 530 in FIG. 22. A band or web like 530 mayalso be used to constrain the size of the connector or a graft (such asa vein graft) relative to the connector. Vein grafts may dilatesignificantly under arterial blood pressure. A band or web can be usedto fix its size relative to the connector. Alternatively or additionallya band or web like 530 can be provided to help seal the completedanastomosis. For purposes of these various kinds, a band or web like 530may preferably be elastic (e.g., of a rubber or rubber-like materialsuch as silicone or polyurethane). The band or web like 530 can beporous, if desired, and may be impregnated with drugs to facilitatehealing and/or sealing. Similarly, polymer patches like 522 in FIG. 21can include and release coagulant and/or other medication to helpprevent bleeding and promote healing. Patches like 522 in FIG. 21 canhelp prevent members like 22 from pulling back through tissue that themember has penetrated.

An important attribute of the connectors of this invention is thecharacteristic that the medial section is soft enough to allow balloonexpansion and strong enough to secure the two body fluid conduits viasuch elements as 22 and 42, 422 and 460/462/464, or 642. To achieve thiswith a single material and wall thickness, which may be preferable froma manufacturing perspective, the center section may be annealedselectively to soften it without compromising the rigidity of theretention elements (e.g., 22, 42, 422, 642, etc.). This can be done, forexample, by laser heat treating the medial section only. The results ofthis process are relatively low hardness in the medial section andrelatively high hardness in the end sections, all within an overalllength of about 0.2 inches.

The connectors of this invention may also be made of a super-elasticmaterial such as nickel-titanium (“nitinol”), which would allow asimilar geometry as stainless steel to self-deploy or actuate in-vivo.

It will be appreciated that the fact that the connectors of thisinvention can be initially relatively small in circumference, and thatthey can be remotely controlled to position them in the patient and tothen annularly expand them for final deployment, facilitates use ofthese connectors and associated apparatus (e.g., apparatus 200) atremote and/or inaccessible locations in a patient. For example, aconnector of this invention may be delivered into and installed in apatient (using apparatus such as apparatus 200) through relatively smallinstrumentation such as laparascopic apparatus, a cannula, or anintraluminal catheter. Thus a connector and associated apparatus (e.g.,apparatus 200) of this invention can be used in any of the proceduresmentioned earlier in this specification, and in particular in proceduresand with other elements shown in any of above-mentioned references WO98/16161, U.S. Pat. No. 5,976,178, U.S. Pat. No. 6,120,432, U.S. Ser.No. 08/869,808, and U.S. Ser. No. 09/187,364. Alternatively, theconnector and/or apparatus (e.g., apparatus 200) of this invention canbe used in more traditional or conventional surgical procedures or inother, known, less invasive or minimally invasive procedures. As justsome examples of possible uses of the connectors and apparatus of thisinvention, they can be used to perform an anastomosis to a beating orstill heart without the use of sutures or direct access.

Again, although the connectors of this invention can be made in varioussizes for various uses, a typical connector is initially less than about1 millimeter in diameter and in the range from about 2 to about 4millimeters in length. After annular enlargement, a typical connector ismore than about 2.5 millimeters in diameter. The pre-yield geometry ofthese connectors is ideal for delivery and positioning; the post-yieldgeometry is ideal for vessel securement, seal, and patency. The geometryof the connectors is ideal for annular enlargement. Radial outwarddeflection of certain connector members such as 22, 42, 422, 642, etc.,is ideal for interfacing the expanding medial section of the connectorto each of the two body fluid conduits to be connected (e.g., a graftvessel and an artery vessel).

As has been explained, certain connector cells may be configured to openbefore other cells as desired to optimize deployment positioning.Integral connector fingers such as 22, 42, 422, 642, etc., can bedeflected radially out from the remainder of a connector for the purposeof attachment to body fluid conduits (e.g., a graft and an artery).These fingers are part of the connector body and can be hooks, barbs,loops, or spikes. The geometry of the fingers can also change, asdesired, in response to balloon expansion. A balloon catheter can beused to actuate the connector and provide an anastomosis opening andattachment. The nose cone portion 220 of apparatus 200 covers theconnector and graft interface, allowing dilation of the other body fluidconduit wall and passage of the connector through that wall. Theconnector provides the actual anastomotic opening and the connectionsimultaneously. The device is actuated via a balloon and catheterdelivery system.

Among the advantages of the invention are that it eliminates suturingand reduces the time required to produce an anastomosis. In majorcirculatory system repair procedures such as cardiac bypass procedures,this can reduce cardiopulmonary pump time, which is of great benefit tothe patient. The invention provides optimal flow dynamics, e.g., from agraft to the coronary artery. The blood entrance angle can be engineeredinto the connector geometry rather than relying on suture skill ortechnique. The invention eliminates possible suture injury to vessels.At the high stress site of an anastomosis sutures are eliminated. Theconnector and a graft can be delivered percutaneously, e.g., as inseveral of the references that are mentioned above. Direct accessrequired for suturing is eliminated. An anastomotic connection can bemade to a beating heart.

What is claimed is:
 1. Apparatus for inserting an annular graftconnector, to which graft tissue is attached, into a side wall of atubular body tissue conduit from outside the conduit comprising: asubstantially conical tip structure having a cone angle less than about15°, configured for passage through the side wall from outside theconduit starting with an apex of the cone, and further configured toreceive and annularly surround at least a portion of the connector whileleaving at least a portion of the graft tissue exposed and thus externalto the confines of the tip structure; and a shaft structure extendingfrom the tip structure in a direction away from the apex and configuredto receive the connector annularly around the shaft structure.
 2. Theapparatus defined in claim 1 wherein the cone angle is in the range fromabout 5° to less than about 15°.
 3. The apparatus defined in claim 1wherein the cone angle is in the range from about 5° to about 10°. 4.The apparatus defined in claim 1 wherein the tip structure is configuredto receive and annularly surround at least a portion of the connector.5. The apparatus defined in claim 1 wherein an axial portion of theconnector is configured to extend through the side wall of the conduit,and wherein the tip structure is configured to axially receive andannularly surround said axial portion of the connector.
 6. The apparatusdefined in claim 1 further comprising: a longitudinal guide structureextending axially from the apex in a direction away from the connector,the guide structure being configured to extend through an aperture inthe side wall and then axially along a lumen inside the conduit.
 7. Theapparatus defined in claim 6 wherein the guide structure is axiallyfixed to the tip structure.
 8. The apparatus defined in claim 6 whereinthe tip structure and the shaft structure are axially reciprocable alongthe guide structure.
 9. The apparatus defined in claim 8 wherein theguide structure extends axially along a lumen through the tip structureand the shaft structure.
 10. The apparatus defined in claim 1 whereinthe shaft structure is configured to extend axially from the tipstructure farther than the connector, and wherein the shaft structure isconnected to the tip structure so that the shaft structure can be usedto push the tip structure in the direction of the apex.
 11. Theapparatus defined in claim 1 further comprising: a radially expandablestructure configured for disposition annularly around the shaftstructure and inside the connector around the shaft structure.
 12. Theapparatus defined in claim 11 further comprising: a tubular memberconfigured for disposition around the shaft structure, the radiallyexpandable structure being secured to the tubular member.
 13. Theapparatus defined in claim 12 wherein the tubular member and theradially expandable structure are reciprocable axially along the shaftstructure.
 14. The apparatus defined in claim 11 wherein the radiallyexpandable structure comprises: an inflatable annular balloon.
 15. Theapparatus defined in claim 4 further comprising: a tubular memberconfigured for disposition around the shaft structure and furtherconfigured for use in keeping the connector received by the tipstructure.
 16. The apparatus defined in claim 15 wherein the tubularmember is further configured to be movable axially along the shaftstructure.
 17. The method of producing a hollow annular anastomoticconnection between a first aperture in a side wall of a body tissueconduit in a patient and a second aperture in a side wall of a graftconduit relocated from elsewhere in the patient's body comprising:introducing a hollow annular connector into the graft conduit so that afirst axial portion of the connector is disposed inside the graftconduit and a second axial portion of the connector extends out of thegraft conduit via the second aperture and into the body tissue conduitvia the first aperture; and deforming the connector so that it pressestogether the side walls of the body tissue conduit and the graft conduitannularly around the first and second apertures.
 18. The method definedin claim 17 further comprising: shielding the second axial portion ofthe connector during at least part of the introducing.
 19. The methoddefined in claim 18 further comprising: unshielding the second axialportion of the connector after the shielding but prior to the deforming.20. The method defined in claim 17 wherein the deforming comprises:annularly enlarging the connector.
 21. The method defined in claim 17wherein the deforming comprises: axially shortening the connector. 22.The method defined in claim 17 wherein the connector is disposedannularly around a selectively inflatable balloon, and wherein thedeforming comprises: inflating the balloon.
 23. The method defined inclaim 22 further comprising: after the deforming, deflating the balloon.24. The method defined in claim 23 further comprising: after thedeflating, removing the balloon from inside the connector and from thepatient.